The following data is part of a premarket notification filed by Quanta System, S.p.a. with the FDA for Litho Dk30.
| Device ID | K141403 |
| 510k Number | K141403 |
| Device Name: | LITHO DK30 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | QUANTA SYSTEM, S.P.A. VIA IV NOVEMBRE,116 Solbiate Olona, IT 21058 |
| Contact | Maurizio Bianchi |
| Correspondent | Maurizio Bianchi QUANTA SYSTEM, S.P.A. VIA IV NOVEMBRE,116 Solbiate Olona, IT 21058 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-28 |
| Decision Date | 2014-08-07 |
| Summary: | summary |